Mark Ellis

• Led tech transfers of 8 development products from R&D to CMC for next generation clinical products. • Created and supported custom equipment maintenance plans and calibrations • Demonstrated cross-functional team leadership in the product development process, streamlining workflows and reducing pre-clinical development time, resulting in the successful launch of eight innovative products into clinical trials. • Mitigated project scope creep by implementing rigorous project management protocols, conducting weekly project stakeholder meetings, and refining project charter, resulting in a 25% reduction in project timeline. • Led six sigma process optimization initiatives to enhance manufacturing RTY by 28% and reduce waste by 50%. • Utilized MS Project and Smartsheet project management software to provide constant project status updates to key stakeholders from manufacturing managers to executive leadership. • Process mapping, WI/SOP/PQ/PFMEA documentation drafting, and BOM creation of medical devices. • Managed $2M capital equipment planning budget to support clinical production commercialization. • Owned deviation management and change controls for Process Development teams. • Program management of pre-clinical product lines and next generation product development. • Presentations of project plan proposals to executive teams with return on investment for branch expansions of in-house production vs. out sourcing for key product supplies for $1M annual savings. • Owned Veeva QMS and document management system rollout while leading and training cross functional groups. • Managed, Coached, and Mentored 7 junior/contract engineers and co-ops into full time roles while directing, coaching and supporting indirect staff of 50+ across 2 shifts.

•Led Industry 4.0 project management initiative to transform manufacturing data acquisition of equipment and software development to optimize production output and reduce downtime. •Directed quoting of new customer products for Swiss cam department to meet cost targets. •Implemented new equipment, SOPs, and manufacturing processes to drive business expansion. •Collaborated with customers for design changes and process improvements to lower cost of products. •Led the development of new product introduction (NPI) processes as the Swiss Department Engineering Lead. • Programmed CNC Swiss lathes using Autodesk Partmaker to enhance manufacturing efficiency. • Evaluated and procured advanced equipment, resulting in improved process capabilities and reduced production time. •Utilized lean six sigma manufacturing principles to reduce COPQ across departments by reducing process handoffs.

• Executed $10M Product Development project, overseeing the complete manufacturing transfer process. • Managed COOPs and interns, successfully transitioning several into full-time roles. • Collaborated with Marketing and Sales to redesign product labeling to expand product to new territories aligning with market strategy. • Developed medical device critical documentation including work instructions, IQ, OQ, PQ, and Manufacturing Control Plans, enhancing operational efficiency. • Specialized in Heat Treatment Furnaces, Final Clean, Passivation, Packaging, Product Assembly and Agile document control and quality management system. • Led six sigma process optimization initiatives to enhance production efficiency by 50% and reduce cycle times by 25%. • Performed hazard analysis to manufacturing processes to reduce risk of injury and maintain compliance. • Utilized Minitab analytical system to validate equipment and process capability. • Assisted audits for FDA, MDSAP, and ANVISA as Subject Matter Expert and back room document support.

• Led master disk project launch of 108 SKUs from product design, cost, market analysis and manufacture in 8 months. • Defined and established measurement procedures for Mahr metrology products, enhancing product quality and reducing scrap of product line by 25%. • Utilized SolidWorks for tool and fixture design, improving efficiency in manufacturing processes and reducing yearly costs by $200k. • Created and updated BOMs, Routers, and SKUs for new and existing products in enterprise management systems.

• Designed custom parts and fixtures for clients using SolidWorks, enhancing product functionality. • Operated manual and CNC Mori Seiki machines to fabricate precision components, ensuring high-quality standards. • Supervised lab operations to maintain a safe and efficient working environment while identifying and procuring necessary materials.

Taught the Design for Manufacturing (MNE 345), Manufacturing Computer Numerical Control (MNE 381) and Senior Design Lab (MNE 497-498) courses. Taught design and manufacturing principals to Junior and Senior students.

• Trained and supervised 3 employees in CNC operation and machine shop practices. • Operated and programmed CNC Swiss Screw Citizen lathes and Okuma lathes, ensuring high-quality production. • Developed and implemented SPC inspection sheets, leading to improved manufacturing time and quality control. • Managed night operations for facility, shipping & receiving, inventory management, and maintenance.

• Set up and operated 3 CNC Citizen and Star lathes, ensuring precision in manufacturing medical components. • Conducted SPC inspections to maintain quality standards and compliance in production processes. • Managed shipping and receiving of products and materials, utilizing crane operations for efficient logistics.

MSEM Gordon Institute

Specialized in Manufacturing Engineering Minor: Business Administration